The disclosures herein relate generally to prosthetic heart valves and more particularly to a shock resistant package for a universal mechanical valve.
Present packaging for a universal mechanical valve includes an inner top barrier member and an inner bottom barrier member for housing the valve. The inner unit is steam sterilized and placed in an outer barrier member also including a top and bottom portion. The valve includes a pyrolite orifice having pyrolitic carbon leaflets. This arrangement permits shock loads to be transmitted directly to the valve components, i.e. orifice and leaflets, during shipping thus increasing the potential for shock induced damage. The purpose of the inner barrier device is to package the valve to be used for either an aortic or mitral orientation, i.e. inverted positions.
Examples of present packaging devices include U.S. Pat. No. 4,101,031 which discloses a package for a prosthetic heart valve or the like comprising a pair of separable mating package sections for receiving the heart valve and retaining it in a sterile manner in a biased position against a resilient pad. A separate retainer member is positioned in the package for biasing the heart valve against the pad, the retainer member being a rigid sheet having an aperture adapted to receive a portion of the valve. One of the mating package sections is provided with a shoulder which urges the retainer member into a biased position against the heart valve so that the valve is in turn biased against the resilient pad. The shoulder is adapted to slide along the surface of the retainer member so that torque is not transmitted to the heart valve when the package sections are rotated to open or close the package.
U.S. Pat. No. 4,801,015 discloses a device for releasably holding an object, particularly a prosthetic heart valve, comprising a handle member integral with a key member which releasably engages a holder member having an interacting engaging screw which controls and limits the movement of integral cooperating fingers for holding and releasing the object. A package assembly is provided for storing, under sterile conditions, a holder member of the device attached to a prosthetic heart valve comprising a clam shell mechanism for releasably holding the holder member and valve.
In U.S. Pat. No. 5,720,391, packaging and a holder are provided for a heart valve prosthesis. The holder is adapted to grasp the heart valve prosthesis and includes a post. The packaging includes a collar for holding the post of the holder. An inner tray of the packaging receives the collar such that the prosthesis is suspended within the inner tray. An outer tray lid receives the inner tray. An inner tray lid seals the inner tray and an outer tray lid seals the outer tray.
In U.S. Pat. No. 5,823,342, packaging for a heart valve device is disclosed that includes a container having an inner compartment. The container has an aortic orientation and a mitral orientation and is connected to be opened in either orientation. The packaging also includes an aortic support member located in the compartment that supports the heart valve device when the container is opened in the aortic orientation. The heart valve device is supported such that it is prepared for receiving a holding instrument for implantation as an aortic valve. The packaging further includes a mitral support member located in the compartment that supports the heart valve device when the container is opened in the mitral orientation. The heart valve device is supported such that it is prepared for receiving a holding instrument for implantation as a mitral valve.
Therefore, what is needed is a packaging container for a universal mechanical valve which preserves the universal nature of the packaging concept while shielding the valve from severe shock loading.